According to Janssen Pharmaceuticals a preplanned early analysis of the Phase III TITAN trial shows that Erleada (apalutamide) has met the both of the trial’s primary endpoints in the treatment of men with metastatic castration-sensitive prostate cancer (CSPC). Janssen has indicated that they will be seeking regulatory approval for this expanded indication.
According to TITAN's primary endpoints, once-daily 240 mg oral Erleada plus androgen deprivation therapy (ADT) significantly improved both radiographic progression-free survival (rPFS) and overall survival (OS) vs. placebo plus androgen deprivation therapy.
TITAN is a double-blind, international trial that enrolled 1,052 newly diagnosed men with metastatic disease, regardless of prognostic risk, volume of disease, prior treatment with docetaxel or therapy of localized disease.
Currently, Erleada is approved in the U.S. to treat non-metastatic castration-resistant prostate cancer (CRPC). If the results from the TITAN trial leads to the approval of Erleada, then the drug can be used in men who are both castrate sensitive and castrate resistant. Currently, the EU is reviewing Erleada for men with non-metastatic castrate resistant prostate cancer (CRPC).